国产盐酸氨溴索片在健康人体内的生物等效性评价

 目的:比较国产和进口盐酸氨溴索片在健康人体内的药代动力学和生物利用度,评价2种制剂的生物等效性?方法:8名男性健康志愿者随机交叉单剂量po 90mg国产或进口盐酸氨溴索片,采用HPLC测定血浆中药物浓度,通过方差分析和双向单侧t检验比较2种制剂的药-时曲线下面积(AUC_0～24)?结果:国产和进口盐酸氨溴索片的c_max为(200.57±25.30)ng·ml^-1和(201.64±23.89)ng·ml^-1;t_max为(1.31±0.26)h和(1.38±0.23)h,t_1/2β为(7.22±1.50)h和(7.86±1.77)h;AUC_0～24为(1225.03±182.32)和(1229.60±276.51)ng·h·ml^-1?结论:国产与进口盐酸氨溴索片生物等效,国产片的相对生物利用度为(101.22±10.25)%?

Bioequivalence evaluation of domestic ambroxol hydrochloride tablets in healthy subjects

OBJECTIVE: To compare the pharmacokinetics and evaluate the bioequivalence of the domestic and imported ambroxol (Amb) hydrochloride tablets. METHODS: 8 healthy subjects were enrolled in a randomized crossover study with a single oral dose of 90 mg of the two formulations respectively.Plasma concentrations of Amb were determined by HPLC.Aera under the drug concentrationtime curve (AUC024) was evaluated by variance analysis and two onesided ttest. RESULTS: A twocompartment open pharmacokinetic model was adopted in Amb plasma concentrationtime data analysis.The peak concentrations of Amb(cmax) were (200.5725.30)ngml-1 and (201.6423.89)ngml-1,time to reach the peak concentrations (tmax) (1.310.26)h and (1.380.23)h,the elimination half life (t1/2) (7.221.50)h and (7.861.77)h,AUC024 (1225.03182.32) and (1229.60276.51) (hngml-1),respectively in the domestic and imported tablets. CONCLUSION: The two formulations were of bioequivalence.The relative bioavailability of the domestic tablet was (101.2210.25)%